Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 23, 2016 | Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant ac... | Drills cannot be inserted into handpiece due to tolerance specification not met | Class II | Straumann Manufacturing, Inc. |
| Nov 23, 2016 | Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant ... | Drills cannot be inserted into handpiece due to tolerance specification not met | Class II | Straumann Manufacturing, Inc. |
| Nov 23, 2016 | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and d... | During use, the unit could separate un-expectantly. This failure would allow the patient's arm t... | Class II | Allen Medical Systems, Inc. |
| Nov 21, 2016 | GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indic... | Endotoxin values from testing of retains slightly exceeded the established specification. | Class II | Tepha Incorporated |
| Nov 16, 2016 | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat... | Class III | PerkinElmer Health Sciences, Inc. |
| Oct 31, 2016 | ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The... | iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). | Class II | ConforMIS, Inc. |
| Oct 31, 2016 | MEVION S250 Product Usage: Proton Radiation Therapy | Completing Setup Without Program Move Complete Can Cause An Isocenter Error | Class II | Mevion Medical Systems, Inc. |
| Oct 28, 2016 | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. ... | Breach in sterile barrier compromising product sterility | Class II | Hologic, Inc |
| Oct 27, 2016 | Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analy... | Possible unintentional x-ray emission after users attempt early termination of the sequence. | Class II | Olympus Scientific Solutions Americas |
| Oct 21, 2016 | MEVION S250 Product Usage: Proton Radiation Therapy System | Recovery of Incorrect Isocenter -operational change | Class II | Mevion Medical Systems, Inc. |
| Oct 20, 2016 | MEVION S250 Product Usage: Proton Radiation Therapy System | Software defect:2D projection of contours in Verity. The defect causes structures to appear off f... | Class II | Mevion Medical Systems, Inc. |
| Oct 19, 2016 | ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur an... | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 19, 2016 | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur an... | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the A... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 18, 2016 | ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Ca... | Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. | Class II | ConforMIS, Inc. |
| Oct 14, 2016 | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigati... | Incorrect lot number on outer kit | Class III | OMNI LIFE SCIENCE |
| Oct 13, 2016 | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677.... | Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for... | Class II | PerkinElmer, Inc |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 5, 2016 | Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test) | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 5, 2016 | Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test) | Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 22, 2016 | Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:... | O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate... | Class II | Medtronic Navigation, Inc.-Littleton |
| Sep 19, 2016 | Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product... | Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... | Class II | Philips Electronics North America Corporation |
| Sep 19, 2016 | Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (... | Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... | Class II | Philips Electronics North America Corporation |
| Sep 19, 2016 | Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GH... | Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and De... | Class II | Philips Electronics North America Corporation |
| Sep 15, 2016 | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 ... | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match t... | Class II | Keystone Dental Inc |
| Sep 2, 2016 | Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812,... | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... | Class III | Siemens Healthcare Diagnostics Inc |
| Sep 2, 2016 | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, ... | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... | Class III | Siemens Healthcare Diagnostics Inc |
| Aug 26, 2016 | HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A | The handle can separate from the MRx housing due to breakage of mounts on the rear case. | Class II | Philips Electronics North America Corporation |
| Aug 22, 2016 | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast bi... | Incorrect label on the Sertera Biopsy Kit | Class II | Hologic, Inc |
| Aug 12, 2016 | PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732... | A defect component of the Compano reader power supply can cause the power supply to burn and some... | Class II | Philips Electronics North America Corporation |
| Aug 11, 2016 | Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 103... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): ... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 9, 2016 | ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/S... | Communication provided to emphasize that the PSA values should be interpreted in accordance with ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 8, 2016 | Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrat... | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.